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2 дня назад

Quality Manager

Формат работы
hybrid
Тип работы
fulltime
Грейд
lead
Английский
b2
Страна
Netherlands/Finland
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TL;DR

Quality Manager (QMS/ISO 13485/EU MDR): Lead the Finland Quality team and ensure effective implementation, maintenance, and continuous improvement of the Evondos Quality Management System across Finland operations with an accent on nonconformance management, CAPA, change control, and post-market quality. Focus on driving audit readiness and translating regulated quality requirements into practical, scalable business processes that support patient safety.

Location: Helsinki or Salo, Finland (Hybrid)

Company

Evondos Group provides medication management solutions that help patients take medication safely at home.

What you will do

  • Lead and develop the Finland Quality team.
  • Own the day-to-day execution of the Evondos QMS across manufacturing, supplier quality, service quality, and post-market quality.
  • Oversee nonconformance management, CAPA, change control, and quality investigations.
  • Monitor quality performance, trends, and continuous improvement initiatives.
  • Support internal and external audits and maintain high audit readiness.
  • Act as the primary Quality partner for Finland operations and collaborate across multiple functions and Group Quality & Regulatory Affairs.

Requirements

  • Fluency in English is required.
  • Strong knowledge of ISO 13485 and quality requirements related to EU MDR.
  • Experience with quality management systems, audits, CAPA, and change control.
  • Several years of experience in quality roles within a regulated industry, ideally medical devices.
  • People leadership or team management experience.
  • Must be eligible to work in the country of work location and hold valid EU work authorization.

Nice to have

  • Finnish language skills.

Culture & Benefits

  • Flexible hybrid working arrangements.
  • Leadership role with direct impact on product quality and patient safety.
  • International and collaborative working environment across functions and countries.
  • Opportunity to develop both people and processes while supporting continuous improvement.

Hiring process

  • Application review based on role requirements and eligibility to work in the location.
  • Interviews to assess quality leadership, regulated quality expertise, and fit for a matrix organization.

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